Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies¶
United States Food and Drug Administration. (2006). Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies: Exploratory IND Studies.
Cited by¶
1 citation across 1 artifact.
Each citation links to the sentence it supports in the citing article.
Domain-specific¶
- Smoke Test
- Under the FDA's 2006 exploratory-IND guidance (and the parallel ICH framework), a sponsor may give a "microdose" — no more than 100 micrograms, and no more than one-hundredth of the dose expected to produce a pharmacological effect — to a small number of human volunteers to measure how the candidate is absorbed, distributed, and cleared, before committing to a full Phase I trial
This sourceThe FDA's exploratory-IND framework, under which microdose and screening studies with very limited human exposure and no therapeutic intent are run early in phase 1.
Supported in partVerified against a saved copy of the source
“has no therapeutic or diagnostic intent (e.g., screening studies, microdose studies)”
- Under the FDA's 2006 exploratory-IND guidance (and the parallel ICH framework), a sponsor may give a "microdose" — no more than 100 micrograms, and no more than one-hundredth of the dose expected to produce a pharmacological effect — to a small number of human volunteers to measure how the candidate is absorbed, distributed, and cleared, before committing to a full Phase I trial
Verification¶
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